AUTHOR=Stuurman Anke L. , Carmona Antonio , Biccler Jorne , Descamps Alexandre , Levi Miriam , Baum Ulrike , Mira-Iglesias Ainara , Bellino Stefania , Hoang Uy , Lusignan Simon de , Bonaiuti Roberto , Lina Bruno , Rizzo Caterina , Nohynek Hanna , Díez-Domingo Javier , DRIVE Study Contributors , Drăgănescu Anca Cristina , Săndulescu Oana , Piţigoi Daniela , Miron Victor Daniel , Streinu-Cercel Anca , Bilaşco Anuţa , Streinu-Cercel Adrian , Florea Dragoş , Vlaicu Ovidiu , Paraschiv Simona , Bănică Leontina , Oţelea Dan , Redlberger-Fritz Monika , Geringer Eva , López-Bernus Amparo , Perez Ana Haro , Zufiaurre Nieves Gutierrez , Muñoz Cristina Carbonell , Martin Miguel Marcos , Bellido Muñoz Juan Luis , Rodríguez Isabel Gil , Alvarez Antonio Muro , Garcia Moncef Belhassen , Icardi Giancarlo , Mosca Stefano , Panatto Donatella , Montomoli Emanuele , Castaldi Silvana , Orsi Andrea , Domnich Alexander , Chironna Maria , Loconsole Daniela , Manini Ilaria , Napoli Christian , Torsello Alessandra , Pariani Elena , Lai and Piero Luigi , Otero-Romero Susana , Pagarolas Andrés Antón , Andrés Cristina , Carbonés Ingrid , Pares Oleguer , Fornaguera Mar , Oller Anna , Salgado Xavier , Tejerina Patricia , Martinez Cristina , Orrico-Sánchez Alejandro , López-Labrador F. Xavier , Mengual-Chuliá Beatriz , Soler Judit Sánchez , Palomino María Jinglei Casanova , Mollar-Maseres Juan , Tortajada-Girbés Miguel , Rodríguez-Blanco Noelia , Carballido-Fernández Mario , Ivorra Raquel Andreu , Fortuny Àngels Sierra , Segura Beatriz Segura , Ureta Cristina Mingot , Díaz-Flores Sagrario Corrales , Pla Ángela Sánchez , Balaguer María Dolores Tirado , Alberola Juan , Nogueira José Miguel , Camarena Juan J , Arjona-Zaragozí Francisco , Benavent Maruan Shalabi , López-Hontangas José Luis , Gómez María Dolores , Martín-Quirós Alejandro , Illana Carlos Cañada , Cendejas Emilio , García Irma Casas , Pinilla Guillermo Mena , Pardo María Esteve , Junquera Lola Álamo , Casañ Cristina , Morodo Sandra Fernandez , Hernández Agueda , Cardona Pere-Joan , Segura Marta , Pelegrin Andreu C. , González-Gómez Sara , Saludes Verónica , Martró Elisa , Thors Valtýr Stefánsson , Björnsdóttir Kristín L. , Luong Liem , Lesieur Zineb , Saidi Yacine , Bauer Rebecca , Pereira Christine , Vanhems Philippe , Lainé Fabrice , Galtier Florence , Duval Xavier , Durier Christine , Bonanni Paolo , Vannacci Alfredo , Ravaldi Claudia TITLE=Brand-specific estimates of influenza vaccine effectiveness for the 2021–2022 season in Europe: results from the DRIVE multi-stakeholder study platform JOURNAL=Frontiers in Public Health VOLUME=11 YEAR=2023 URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1195409 DOI=10.3389/fpubh.2023.1195409 ISSN=2296-2565 ABSTRACT=Introduction

Development of Robust and Innovative Vaccine Effectiveness (DRIVE) was a European public–private partnership (PPP) that aimed to provide annual, brand-specific estimates of influenza vaccine effectiveness (IVE) for regulatory and public health purposes. DRIVE was launched in 2017 under the umbrella of the Innovative Medicines Initiative (IMI) and conducted IVE studies from its pilot season in 2017–2018 to its final season in 2021–2022.

Methods

In 2021–2022, DRIVE conducted four primary care-based test-negative design (TND) studies (Austria, Italy, Iceland, and England; involving >1,000 general practitioners), nine hospital-based TND studies (France, Iceland, Italy, Romania, and Spain, for a total of 21 hospitals), and one population-based cohort study in Finland. In the TND studies, patients with influenza-like illness (primary care) or severe acute respiratory infection (hospital) were enrolled, and laboratory tested for influenza using RT-PCR. Study contributor-specific IVE was calculated using logistic regression, adjusting for age, sex, and calendar time, and pooled by meta-analysis.

Results

In 2021–2022, pooled confounder-adjusted influenza vaccine effectiveness (IVE) estimates against laboratory-confirmed influenza (LCI) overall and per type and subtype/lineage was produced, albeit with wide confidence intervals (CI). The limited circulation of influenza in Europe did not allow the network to reach the optimal sample size to produce precise IVE estimates for all the brands included. The most significant IVE estimates were 76% (95% CI 23%−93%) for any vaccine and 81% (22%−95%) for Vaxigrip Tetra in adults ≥65 years old and 64% (25%−83%) for Fluenz Tetra in children (TND primary care setting), 85% (12%−97%) for any vaccine in adults 18–64 years (TND hospital setting), and 38% (1%−62%) in children 6 months−6 years (population-based cohort, mixed setting).

Discussion

Over five seasons, DRIVE collected data on >35,000 patients, more than 60 variables, and 13 influenza vaccines. DRIVE demonstrated that estimating brand-specific IVE across Europe is possible, but achieving sufficient sample size to obtain precise estimates for all relevant stratifications remains a challenge. Finally, DRIVE's network of study contributors and lessons learned have greatly contributed to the development of the COVID-19 vaccine effectiveness platform COVIDRIVE.